Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail
Study Details
Study Description
Brief Summary
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Detailed Description
This study is a Type 1 hybrid effectiveness-implementation trial. County jails willing to provide extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-B) will participate in a randomized controlled trial throughout the state of Maryland, in which 240 incarcerated men and women will be randomly assigned within gender within jail to one of two arms: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a treatment program. Arm 2. XR-NTX (n=120). XR-NTX in jail, followed by 6 monthly injections post-release at a treatment program. In addition to the RCT the investigators will use a learning collaborative to examine the acceptability and feasibility of medications for opioid use disorder (MOUDs). Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received). Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. To use a learning collaborative involving all 7 RCT county jurisdictions as well as 3 additional counties that selected not to participate in the randomized trial to understand factors related to: (a) acceptability of providing long-acting agonists and antagonists in jail settings; and (b) feasibility of providing medication continuity of care from jail to community treatment providers. Aim 3. Calculate the cost to the correctional health system of implementing an XR-B or XR-NTX program, and determine the relative value of each strategy, including the costs associated with the subsequent interventions in the community, from a state-policymaker and societal perspective.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: XR-B Extended-release buprenorphine |
Drug: XR-B
Individuals will receive extended-release buprenorphine, administered as a subcutaneous injection, is available in seven different dosage strengths for weekly (8, 16, 24, and 32 mg) and monthly (64, 96, and 128 mg) administration by a health care professional.
Other Names:
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| Active Comparator: XR-NTX Extended-release naltrexone |
Drug: XR-NTX
Injectable naltrexone will be used, at a dose of 4cc (380mg of naltrexone), administered by intramuscular injection to the buttocks (alternating sides monthly). Individuals will receive monthly injections.
Other Names:
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Outcome Measures
Primary Outcome Measures
- pharmacotherapy adherence [6-months post-release]
number of monthly injections received (0-6)
Secondary Outcome Measures
- illicit opioid urine screening test results [1-7,12-months]
number of illicit opioid positive urine drug screen results
- self-reported illicit opioid use [Baseline, 1-7,12-months]
self reported days of illicit opioid use
- overdose events [Baseline, 1-7,12-months]
number of fatal and non-fatal overdoses
- Patient-Reported Outcomes Measurement Information System [Baseline, 1-7,12-months]
physical, mental, and social health scored 0: Death scored < 1: A state worse than perfect health
- Risk Assessment Battery (RAB) [Baseline, 1-7,12-months]
HIV risk behaviors; total score/40 (range=0-1)
- Criminal activity [Baseline, 1-7,12-months]
number of days committed crime (20 crimes)
- Re-arrest [12-months]
time to rearrest (days to arrest)
- Re-incarceration [12-months]
time to re-incarceration (days to re-incarceration)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult male or female inmates at participating jails who are eligible for release within 120 days
-
History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration)
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Suitability for XR-B and/or XR-NTX treatment as determined by medical evaluation
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Willingness to enroll in XR-B or XR-NTX treatment in jail
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Planning to live in one of the 7 participating counties and/or surrounding counties
Exclusion Criteria:
-
Liver function test levels greater than 4 times normal;
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Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable);
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Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant)
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Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed);
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History of allergic reaction to naltrexone and/or buprenorphine;
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Current chronic pain diagnosis for which opioids are prescribed;
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Pregnancy (for women);
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Breast-feeding (for women);
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Suicidal ideation (within the past 6 months);
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Body Mass Index (BMI) > 40;
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Inability to pass a study enrollment quiz;
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Currently enrolled in jail-based MOUD pharmacotherapy (methadone, buprenorphine, naltrexone)
-
Enrolled in a methadone treatment program in the past 30 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Friends Research Institute | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- Friends Research Institute, Inc.
Investigators
- Principal Investigator: Michael S Gordon, DPA, Friends Research Institute, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1UG1DA050077